Accomplished and tenacious biopharmaceutical researcher and manager with extensive experience in leading the development of new clinical and research technologies and in guiding business and product development by new and established companies.

Profile: Executive * Translational Scientist * Consultant

Accomplished and tenacious biopharmaceutical researcher and manager with extensive experience in leading the development of new clinical and research technologies and in guiding business and product development by new and established companies.

Cardiome Pharma is a research & development-based biopharmaceutical company dedicated to the discovery, development, and commercialization of new therapies focusing on the treatment of atrial fibrillation and heart failure with one product, Brinavess™ (vernakalant IV) approved in Europe and partnered with Merck.

Director of Cardiovascular Genomics & Bioinformatics, 2007–2012

Identified, recommended, and facilitated the integration of current and new bioinformatics and genomic technologies to assist in development and preclinical and clinical testing of the company’s pharmaceutical product pipeline. Designed biomarker strategies and complimentary animal models for early preclinical studies and worked with project teams to advance biomarker, genetic, and translational medicine study plans. Advanced project milestones with the goal of identifying individuals who do not respond to particular drugs.

Artesian Therapeutics was a discovery-based biotechnology company that translated the gene expression technology and transcriptome content from gene logic into therapeutic drug leads. Artesian was a spinout from Gene Logic Inc. a company based on using of new gene-expression technology to determine gene-expression patterns in diseased tissue and cells.

Gene Logic was a discovery-based biotechnology company that pioneered gene-expression based content comparing transcriptomic profiles from diseased tissue and cells to healthy, normal equivalents. The company licensed this content to major pharmaceutical firms for drug target discovery, with focus in multiple disease categories including cardiovascular, cancer, and cns.

Designed and deployed the largest known database for heart failure and vascular disease in collaboration with Proctor & Gamble, Temple University Medical School, and Tufts University.

Intrexon Corporation is a billion dollar capitalized company that designs novel gene therapy solutions. Intrexon’s approach is to combine the principles of precision engineering, statistical modeling, automation, and production at an industrial scale for the development of improved or novel products.

Provides molecular engineering support for the company’s programs and pharma partnering in terms of proprietary gene design technology needs to facilitate drug and/or product development across a spectrum of corporate divisions and sectors.

Works closely with the Chief Scientific Officer, President, Human Therapeutics Division (HTD), and the Cell Engineering Unit (CEU) to accelerate translation of gene therapy technology to applications in the clinic.

Ablitech – Baltimore, MD 2012

A startup firm with a proprietary technology for delivering nucleic acid-based drugs, the firm has received approximately $2M in funding through a Department of Defense contract.

Director, Scientific Advisory Board

Assembled and presently lead an advisory board of recognized scientific experts to guide corporate goals and ensure scientific integrity. The board oversees multiple grant-funding initiatives and maximizes capitalization for forward-looking fiscal objectives and assists the CEO in identifying and enabling private equity investors. It also manages all translational application of the core technology and identifies appropriate corporate and academic partnerships.

Cardiome Pharma Corporation – 2005 to 2012

Head, Infectious Disease Pilot Program, 2011–2012

As described above – Ion channel infectious disease therapeutics program

Conceived and developed a novel viral ion channel target program using synthetic biology approaches for the screening and testing of new, best-in-class antiviral molecules.

Develop and implement a screening platform to identify novel inhibitors of the viroporins for several problem viruses.

Determine the effectiveness of identified molecules to block the life cycles of HCV, Dengue, and Influenza viruses.

Implement strategy for validation, IND filing, and progression into the clinic.

Seek and execute new pharma partners for development of ion channel-based antivirals.

Director of Scientific Affairs

Performed due diligence of scientific and technical literature and prepared reports for IND submissions to the FDA and for corporate and venture partners of startup companies in these spaces. Served as a primary consultant for new product development to pharmaceutical and medical device companies.

Human Genome Sciences, Inc. – Rockville, MD 1993–1997

A biopharmaceutical corporation founded in 1992, it utilizes the human genome to develop protein and antibody drugs and, in partnership with such firms as GlaxoSmithKline, have drugs under development to treat such diseases as hepatitis C, systemic lupus erythmatosis, anthrax, and cancer.

Senior Scientist

Identified, sequenced, and cloned novel human genes for the development of therapeutic proteins. Performed bioinformatics analysis on novel human genes, and prioritized gene selection for therapeutic development. Led the acquisition of all human tissues and sequencing of genes from those tissues. Supervised two technicians and was a key contributor to the development of one of the world’s largest bioinformatics databases.

Co-authored patents for 182 secreted proteins as therapeutic development candidates.

Identified and cloned novel seven-transmembrane receptors for development by GlaxoSmithKline (GSK).

Education

The Johns Hopkins Oncology Center, The Johns Hopkins University 1985–1989

Postdoctoral Fellow / Junior Faculty Member (Instructor)

Studied mechanisms of viral latency, and molecular mechanisms of interferon action. Participated in department programmatic development and teaching and authored multiple publications and book chapters.

Discovered DNA methylation as a mechanism for HIV latency and mechanisms of HIV activation by herpes simplex and cytomegalovirus.

Developed novel recombinant gene therapy modalities for the inhibition of HIV transcription.

Temple University School of Medicine Ph.D. in Biochemistry, 1985

M.S. in Biochemistry, 1982

Rider University B.A. in Biology, 1980

Grants & Contracts

Canadian Institutes of Health Research (CIHR). A Novel Approach for the Discovery & Development of New Antiviral Therapeutics (Awarded); Partnered Operations Grant Application – Cardiome Pharma Corp. & University of British Columbia (2012). Total $1,900,000 for 5 years.

American Foundation for AIDS Research (AmFAR). Methylation as a Modulator of Expression of HIV. Research Grant #RG-000639 (1989-1991); Total direct costs $50,000; Total indirect costs $9,100.

The National Institutes of Health (NIH). Regulation of HIV Latency by Methylation of Proviral DNA. Young Investigator Award; #1-R29-AI-28567-01A1-ARR3 (1989). Total direct costs $350,000; Total indirect costs $224,686.

BIOSKETCH: Daniel Bednarik was previously Director of Genomics and Bioinformatics for Cardiome Pharma Corporation. He was previously co-founder and Vice President of Cardiovascular Biology of Artesian Therapeutics, Inc., which was acquired by Cardiome in 2005. Dr. Bednarik served as a consultant for Cardiome for two years and was subsequently hired in 2007 to develop genomic and proteomic biomarker programs to help augment and accelerate clinical trial design. He created the largest known cardiovascular gene expression database for Gene Logic. Dr. Bednarik served as a key scientist for the development of Human Genome Sciences’ (HGS) database and has over 28 years experience in the field of virology with emphasis on HIV and herpes virus pathology. He was co-recipient of a DARPA contract in 2006 where he and his colleagues developed a novel non-host method for rapid vaccine manufacture. Dan also is experienced in developing and managing clinical programs. His training was completed at Temple University School of Medicine (Philadelphia) in 1985, and The Johns Hopkins University Oncology Center (Baltimore).

IN MY CURRENT POSITION OF SENIOR DIRECTOR, MOLECULAR ENGINEERING UNIT (MEU) OPERATIONS, I provide molecular engineering support for the company’s programs and “External Channel Partner” collaborations in terms of proprietary gene design technology needs to facilitate drug and/or product development across a spectrum of corporate divisions and sectors. Works closely with the Chief Scientific Officer (MEU), President, Human Therapeutics Division (HTD), and the Cell Engineering Unit (CEU) to accelerate translation of technology to application in the clinic or other venues.